Ankle Braces for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Cerebellar stroke, Neurologic conditions, Sensorimotor neglect, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing ankle braces, so it's likely you can continue your medications, but please confirm with the study team.

What data supports the effectiveness of the treatment Dynamic Ankle-Foot Orthosis for stroke patients?

Research shows that ankle-foot orthoses (AFOs) can improve balance and reduce fall risk in stroke patients with spasticity (muscle stiffness). Additionally, dynamic AFOs have been found to enhance walking ability in hemiparetic adults (those with weakness on one side of the body) by improving ankle movement. ^{1 2 3 4 5}

Is it safe to use ankle braces for stroke recovery?

Ankle-foot orthoses (AFOs), including various designs like the anterior encased ankle foot orthosis (AEAFO), have been used safely in stroke patients to help with walking and balance. They are generally considered safe, with satisfactory strength and durability in clinical applications. ^{1 2 5 6 7}

How is the Dynamic Ankle-Foot Orthosis treatment different from other treatments for stroke?

The Dynamic Ankle-Foot Orthosis (DAFO) is unique because it is designed to improve walking by allowing more natural ankle movement compared to standard ankle-foot orthoses, which are often rigid. This dynamic design helps enhance balance and reduce the risk of falls in stroke patients. ^{1 2 3 5 8}

Eligibility Criteria

This trial is for individuals who have had a stroke and are experiencing difficulties with walking due to ankle joint issues. Participants should be able to walk at least some steps, even if assistance is needed. There's no specific mention of exclusion criteria in the provided information.

Inclusion Criteria

I have been prescribed an ankle-foot orthosis (AFO) by my doctor.

I can't do 25 standing heel-raises due to weakness.

I had a stroke more than 6 months ago.

Exclusion Criteria

Individuals with sensorimotor neglect

I have not had a heart bypass or heart attack in the last 3 months.

My MRI shows I had a stroke affecting the back part of my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will walk with a brace under five different assistance level conditions to determine the optimal customization method

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dynamic Ankle-Foot Orthosis

Trial Overview The study tests different levels of stiffness in ankle-foot orthoses (braces) to find out which level helps improve walking the most after a stroke. It aims to create guidelines for clinicians on prescribing the right brace based on individual needs.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Findings from Research

In a study involving 105 stroke patients, the therapist-made SWIFT Cast AFO was used significantly more during physical therapy sessions compared to conventional AFOs, indicating better integration into rehabilitation.

Despite higher usage of the SWIFT Cast, there was no significant improvement in walking speed compared to conventional therapy, suggesting that while it is a low-cost and adaptable option, it may not enhance recovery outcomes beyond standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial. Pomeroy, VM., Rowe, P., Clark, A., et al.[2022]

A systematic review of 60 studies on ankle-foot orthotics (AFO) for individuals with stroke and cerebral palsy found that most interventions improved walking speed and ankle dorsiflexion, indicating their efficacy in enhancing mobility.

However, many studies lacked detailed information on the severity of lower limb impairments and other confounding factors, suggesting a need for more comprehensive research to better understand the impact of AFOs on knee stability and overall function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ankle-foot orthotic management in neuromuscular disorders: recommendations for future research. Chisholm, AE., Perry, SD.[2022]

The Chignon orthosis significantly improved free-walking speed in chronic hemiplegic patients, achieving an average speed of 0.81 m/s compared to 0.64 m/s without any orthosis (p<0.001).

Both the Chignon and prefabricated ankle-foot orthoses (PAFO) reduced the mechanical work required during gait, but the Chignon orthosis also enhanced ankle kinematics, particularly at heel strike and toe-off, indicating better functional performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Chignon dynamic ankle-foot orthosis using instrumented gait analysis in hemiparetic adults. Bleyenheuft, C., Caty, G., Lejeune, T., et al.[2022]

A study of 237 stroke patients using the Patient-Reported Outcome Measures Information System® revealed that their self-reported physical function (PF) was significantly impaired, with a mean T-score of 30.8, indicating they are two standard deviations below the general population average.

Factors such as the need for more supportive assistive devices, recent ankle problems, and greater living assistance were identified as predictors of worse self-reported PF, highlighting the importance of these characteristics in planning effective AFO interventions for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthotic Research Initiative for Outcomes aNalysis (ORION I): predictors of PROMIS PF for stroke survivors seeking orthotic intervention. DiBello, SA., Wurdeman, SR., Gorniak, SL.[2023]

The study involving 25 chronic post-stroke hemiparetic patients demonstrated that using prefabricated thermoplastic posterior leaf spring ankle foot orthoses (PLS-AFO) significantly improved balance, as indicated by an increase in Berg Balance Scale scores from 42.12 without AFO to 47.52 with AFO.

The use of PLS-AFO also reduced fall risk, with stability scores improving from 3.35 without AFO to 2.69 with AFO, highlighting its effectiveness in enhancing safety for patients with mild to moderate spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ankle-foot orthosis improves balance and reduces fall risk of chronic spastic hemiparetic patients. Cakar, E., Durmus, O., Tekin, L., et al.[2016]

The new anterior encased ankle foot orthosis (AEAFO) design effectively corrects hemiplegic gait problems by controlling foot inversion and ankle plantar flexion in patients with stroke and head injuries.

The AEAFO is easy to fabricate and readjust in occupational therapy clinics, showing promising preliminary results in terms of strength, durability, and clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low temperature plastic anterior encased ankle foot orthosis: construction and preliminary clinical results. Chang, JJ., Su, CY.[2016]

In a study involving 23 individuals with unilateral hemiparesis due to stroke, the use of ankle foot orthoses (AFOs) significantly improved their functional stability, as measured by the Functional Reach Test, in all directions (p < 0.05).

The findings suggest that AFOs can play a crucial role in enhancing balance rehabilitation for stroke patients, indicating their potential as an effective intervention for improving postural stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of ankle foot orthoses in functional stability of individuals with stroke. Rao, N., Aruin, AS.[2017]

Ankle foot orthoses (AFOs) have been shown to positively impact ankle movement during the gait of individuals with hemiplegic stroke, particularly in the stance and swing phases.

The articulated passive AFO demonstrated better effects on certain gait parameters compared to non-articulated passive AFOs, but most studies only evaluated short-term effects, indicating a need for further research on long-term outcomes and comparisons among AFO designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different designs of ankle-foot orthoses on gait in patients with stroke: A systematic review. Daryabor, A., Arazpour, M., Aminian, G.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Evaluation of the Efficacy of an Ankle-Foot Cast on Walking Recovery Early After Stroke: SWIFT Cast Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Ankle-foot orthotic management in neuromuscular disorders: recommendations for future research. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Assessment of the Chignon dynamic ankle-foot orthosis using instrumented gait analysis in hemiparetic adults. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Orthotic Research Initiative for Outcomes aNalysis (ORION I): predictors of PROMIS PF for stroke survivors seeking orthotic intervention. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

The ankle-foot orthosis improves balance and reduces fall risk of chronic spastic hemiparetic patients. [2016]

6. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

A low temperature plastic anterior encased ankle foot orthosis: construction and preliminary clinical results. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Role of ankle foot orthoses in functional stability of individuals with stroke. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Effect of different designs of ankle-foot orthoses on gait in patients with stroke: A systematic review. [2019]